Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin
NCT ID: NCT02616354
Last Updated: 2015-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
24 participants
INTERVENTIONAL
2015-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group I
Group I received intravenous imipenem/cilastatin 1 g every 8 h (q8h) or 0.5g every 6 h (q6h) with optimized two-step infusion therapy (OTIT; rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours) "Group I" is more informative than "Group II" from PK parameters(%T\>MIC,AUC/MIC).
Imipenem
Patients in group I received a dose of imipenem/cilastatin 1g each every 8 hours or 0.5g every 6 hours optimized two-step infusion therapy (rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours)
Group II
group II received intravenous imipenem/cilastatin 1g q8h or 0.5g q6h with extended infusion therapy (2-hours continuous infusion in a constant speed).
"Group I" is more informative than "Group II" from PK parameters(%T\>MIC,AUC/MIC).
Imipenem
Patients in group I received a dose of imipenem/cilastatin 1g each every 8 hours or 0.5g every 6 hours optimized two-step infusion therapy (rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours)
Interventions
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Imipenem
Patients in group I received a dose of imipenem/cilastatin 1g each every 8 hours or 0.5g every 6 hours optimized two-step infusion therapy (rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* treatment with imipenem/cilastatin (recommended by hospital microbiologists)
* expected duration of hospital stays in the ICU ≥ 72 h from recruitment
* recruited patients agreed to participate in this trial, and had set up a signed informed consent
Exclusion Criteria
* acute or chronic renal failure assessed by serum creatinine concentrations \> 280 μmol/L (or creatinine clearance \<20mL/min) or those requiring continuous renal replacement therapy
* drug or alcohol abuse
* Pregnant and lactant women
* patients near to death
18 Years
75 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Southeast University, China
OTHER
Responsible Party
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Jianfeng Xie
Deputy director of the physician
Locations
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Kang Xu
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Huang Y, Xu K, Zhan Y, Zha X, Liu S, Xie J, Liu L, Li Q, Shao H, Yang Y. Comparable Effect of Two-Step Versus Extended Infusions on the Pharmacokinetics of Imipenem in Patients with Sepsis and Septic Shock. Adv Ther. 2020 May;37(5):2246-2255. doi: 10.1007/s12325-020-01339-5. Epub 2020 Apr 10.
Other Identifiers
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Two-step Dosing Of Imipenem
Identifier Type: -
Identifier Source: org_study_id